There is controversy in Peru, of all places, about the experimental use
of a treatment for diarrhea in children. Diarrhea is a major
cause of mortality in underdeveloped nations, especially in children.
From the Wikipedia page on infant
mortality:

Major causes of infant mortality in more developed
countries include congenital malformation, infection, and SIDS. The
most common cause of infant mortality of all children around the world
has traditionally been dehydration from diarrhea.
Because of the success of spreading information about Oral Rehydration
Solution (a mixture of salts, sugar and water) to mothers around the
world, the rate of children dying from dehydration has been decreasing
and has become the second most common cause in the late 1990s.
Currently the most common cause is pneumonia.

Clearly, diarrhea remains one of the most pressing world health
problems today. Therefore, it makes sense to try to develop
effective, inexpensive treatments. As long as they are safe.
In this post, I describe the controversy and possible legal
action against a researcher who was attempting to address this problem.
I then ponder the ethical and political issues involved.

Dr. Zavaleta was studying a product made by enhancing oral rehydration
solution with Lactiva™ (recombinant human lactoferrin)
and Lysomin™ (recombinant human lysozyme).
The protein additives are made by Ventria
Bioscience.

The company’s press release about Lactiva and Lysomin is here.
Their description of the study is here.
The study shows that the use of Lactiva and Lysomin helps
kids with diarrhea recover more quickly, lowers the severity of illness, and lowers
the rate of relapse. The results are clinically significant.
Moreover, nobody is questioning the validity of the results,
nor denying their significance.

One of the issues here is the way the study was conducted.

On one hand, the study could be viewed as a nice example of a
benevolent public health initiative. Identify a major health
problem, figure out an inexpensive and accessible way to intervene,
then do the studies to assess safety and effectiveness. If
safety and efficacy results meet appropriate standards, then you can go
ahead and save a lot of lives.

On the other hand, some people have developed a more cynical view.
They see this as a powerful, amoral American corporation
experimenting on kids from a third-world country, ignoring basic safety
concerns while trying to make a buck.

The controversy is described in an AP article in the Washington Post here.
)If that article has disappeared by the time you read this,
there is a permanent file in the NYT RSS archive here.)

LIMA,
Peru — It should have been a triumphant moment for Dr. Nelly Zavaleta
when many of the diarrhea-stricken babies she treated with an
experimental U.S. drug got better quicker than expected.

Instead,
one of Peru’s top scientists finds herself a target of a criminal
investigation, a professional ethics complaint and at the center of a
global debate over food crops genetically engineered with human genes
to produce drugs…

In order to understand the controversy, it is necessary to enumerate
the issues. One, it is alleged that the study was done
without the informed consent required by law in Peru. Two, it
is alleged that the products are dangerous. Three, it is
alleged that the technology used to create the products is dangerous.

I am hardly an expert on Peruvian law, so I can’t comment much on that.
I can say that informed consent is an important part of any
research involving human subjects. Dr. Zaveleta states that
she followed the law, and I don’t see any reason to doubt that.
If she did not, then a routine investigation will reveal
that. it is not a complicated issue. If there are
records that the study was approved by a human subjects review board,
and there is documentation that the study was conducted in accordance
with the the board’s approval, and there are properly signed consent
forms, then there is no problem.

Regarding the allegation that Lactiva and Lysomin are dangerous: the
notion is ridiculous. Both are proteins that are found in
human milk. They are made by putting human genes in rice
plants, then growing the rice to produce the proteins inexpensively, in
large quantities. A straightforward analysis should show that
the proteins produced in this way are identical to those found in
ordinary human milk. It is very difficult to even imagine a
scenario in which such a thing could be dangerous.

Even if there is some obscure danger, given the magnitude of the
diarrhea problem (two million infant fatalities per year, worldwide),
the danger would have to be pretty serious to outweigh the benefit.
The addition of Lactiva and Lysomin to oral
rehydration solution simply is not an issue.

The more nettlesome issue is that regarding the safety of
genetically-modified crops. For background information, see
the Union of Concerned Scientists’ section on Genetic
Engineering. That is something I plan to elaborate
upon in a post tomorrow.

Comments

My daughter was born in Peru in 1989. During the six weeks it took for her adoption to be finalized, she suffered one really dreadful bout of diarrhea. As a ‘wealthy’ foreigner, I was able to promptly summon a taxi that took us to the Anglo-American Clinic. Cost of roundtrip via taxi: 2 dollars. Doctor’s fee: 12 dollars. Other small sums went for lab tests and the Peruvian version of Pedialyte. Let’s say the episode cost, at maximum, 20 dollars, a paltry sum for a university professor from the U.S. But my daughter’s birthmom made only the equivalent of three dollars in cash per month, the rest of her ‘income’ consisting of the room and board she was entitled to as a domestic. When it came to getting health care for her children, she had vastly fewer options than I did. As I think about my daughter’s first mother, I cannot help but have some concerns about the prospect of adding proteins to oral rehydration solutions. On the one hand, even if it turns out that there were irregularities in the testing process, I would hope the ‘baby doesn’t get thrown out with the bathwater’. If there is a way to make oral rehydration solutions even more effective than they are presently, the method should not not cast aside for political reasons. On the other hand, problems could arise if patent holders insist on squeezing out every last possible penny of profit. To me, this would be the most serious objection to the new procedure. Sugar and salt are cheap and easily available. However, the addition of proteins via a proprietary process might in the end have a negative effect if people are steered away from a cheap solution to one that is more expensive and therefore less likely to be utilized. I can imagine my daughter’s birthmother mixing together salt, sugar, and water–she could get these ingredients from her employer’s kitchen. It is not so easy to imagine her getting time off work, making her way to the pharmacy, and parting with a portion of the little cash she would have on hand. So I think one could legitimately object to the addition of the proteins if the a company’s desire to push a patented ORS results in the vitiation of campaigns to educate people about cheap, generic ORS.

Thank you for the comment. Certainly, the track record of companies promoting infant formula in third-world countries gives us a reason to worry that corporate profit motives could lead to bad outcomes. On the other hand, I have no specific reason to be skeptical about Ventria. They are not even selling any product yet, so we have yet to see how ethically they will conduct their business.

What is important is that policymakers think critically about the best use of the limited healthcare resources in any given area, and not get seduced into paying for a high-tech product if it does not result in a proportionate improvement in outcome.

WASHINGTON Stung by reports of widespread problems with Medicare’s new prescription-drug program, the nation’s top health care official said Tuesday that the government is on the case and counseled seniors: “Don’t leave the pharmacy without your drugs.” WBR LeoP

WASHINGTON Stung by reports of widespread problems with Medicare’s new prescription-drug program, the nation’s top health care official said Tuesday that the government is on the case and counseled seniors: “Don’t leave the pharmacy without your drugs.” WBR LeoP